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A Phase II Study of Weekly Paclitaxel, Cisplatin and Concurrent Radiation Therapy for Locally-Advanced Unresectable Non-Small Cell Lung Cancer: Early Closure due to Lack of Efficacy

이재웅|조은경|임영희|정성환|이규찬|방수미|이재훈|안창혁|김미경|경선영|신동복|박정웅|박세훈
대한암학회 (Korean Cancer Association)|2004.10|Cancer Research and Treatment|제36권 제5호|pp. 293-297

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키워드

RadiotherapyCisplatinPaclitaxelNon-small cell lung carcinoma
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초록

Purpose: In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC). Materials and Methods: Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m2 and paclitaxel 40 mg/m2/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, were planned after completion of the TRT. Results: Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity. Conclusion: The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT. (Cancer Res Treat. 2004;36:293-297)

Abstract

Purpose: In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC). Materials and Methods: Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m2 and paclitaxel 40 mg/m2/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, were planned after completion of the TRT. Results: Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity. Conclusion: The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT. (Cancer Res Treat. 2004;36:293-297)

참고문헌 (23)

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관련 논문AI추천

Efficacy of Combination Chemotherapy with Paclitaxel and Cisplatin in Patients with Advanced Non-Small Cell LungCancer이승세, Eun Jung Rhee, Hyun Sik Jeong대한암학회 · Cancer Research and Treatment2002 · 제34권 제1호Preliminary Results of Paclitaxel, Cisplatin and Concurrent High-Dose Radiation Therapy for Locally AdvancedNon-Small-Cell Lung Cancer김동순, 김상위, 김우성, 김원동, 김종훈, 노영주, 서철원, 안승도, 오석중, 이상도, 이상욱, 이정신, 최은경, Kyoung Ju Kim대한암학회 · Cancer Research and Treatment2002 · 제34권 제5호Clinical Responses and Prognostic Indicators of Concurrent Chemoradiation for Non-small Cell Lung Cancer강진형, 김연실, 김영균, 박재길, 안명임, 왕영필, 유이령, 윤세철, 이동수, 이상남, 장홍석, 최병옥, 한대희대한암학회 · Cancer Research and Treatment2011 · 제43권 제1호Effect of Combination Chemotherapy with Docetaxel Plus Cisplatin in Patients with Advanced Non-Small Cell LungCancer강희정, 김민경, 김영길, 류헌모, 배성화, 이경희, 이재륜, 현명수대한암학회 · Cancer Research and Treatment2003 · 제35권 제4호Randomized, Multi-center Phase II Trial of Docetaxel Plus Cisplatin Versus Etoposide Plus Cisplatin as the First-line Therapy for Patients with Advanced Non-small Cell Lung Cancer이상재, 최정혜, Chang-Yeol Yim, Chul-Soo Kim, Dae-Sik Hong, Hanlim Moon, Hee-Sook Park, Jong-Ho Won, Joo-Hang Kim, Jung-Ae Lee, Kab-Do Jung, Keun-Seok Lee, Moon-Hee Lee, Myung-Ju Ahn, Nam-Su Lee, Se-Kyu Kim, Suk-Chul Yang, Su-Taek Uh, Yl-Sub Lee, Yong-Chul Lee대한암학회 · Cancer Research and Treatment2005 · 제37권 제6호Combination of Gemcitabine and Cisplatin as First-Line Therapy in Advanced Non-Small-Cell Lung Cancer박성규, Chan-Kyu Kim, Dae-Sik Hong, Hee-Sook Park, Jae-Ho Byun, Jong-Ho Won, Kyu-Taeg Lee, Nam-Su Lee, Sang-Byung Bae대한암학회 · Cancer Research and Treatment2004 · 제36권 제3호

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